Active — Not RecruitingNot Applicable

Digitally-Captured Step Counts for Evaluating Performance Status in Advanced Cancer Patients

United States80 participantsStarted 2018-12-05

Plain-language summary

The purpose of this study is to examine the relationships between objectively measured physical activity and provider-assessed and patient-reported functional outcomes in patients with advanced cancer. Findings from this study will help us better understand how change in daily physical activity, as measured using the wearable activity monitor, is related to change in a patient's functional status and clinical condition.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of advanced (stage 3 or 4) cancer of any type * Ambulatory (use of walking aids, such as cane and rollator, is acceptable) * Access to a device that has the capability to sync to the Fitbit * Expected to have standard of care oncology appointments at least once every 8 weeks (+/-7 days). * Have an understanding, ability, and willingness to fully comply with study procedures and restrictions * English or Spanish speaking * Ability to consent * Informed consent obtained from subject and ability for subject to comply with the requirements of the study. Exclusion Criteria: * Allergy to surgical steel or elastomer/rubber * Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute change in average step counts at 8 weeks from baseline

Timeframe: 8 weeks

Absolute change in provider-assessed ECOG Performance Status at 8 weeks from baseline

Timeframe: 8 weeks

Trial details

NCT IDNCT03757182

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12-31

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